ALPRAZOLAM-GA alprazolam 2mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alprazolam, Quantity: 2 mg

Available from:

Medis Pharma Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate

Administration route:

Oral

Units in package:

50 tablets

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

INDICATIONS: Anxiety: the short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. Panic Disorder: the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.

Product summary:

Visual Identification: White, rectangular flat-faced on one side tablet. Engraved "'APO 2" with centre partial bisect & 2 bisects on upper side. Deep centre bisect with sloped-faces toward 2 bisects onlower side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-06-25

Patient Information leaflet

Page 1
ALPRAZOLAM-GA
Alprazolam _(al-PRAZ-oh-lam)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Alprazolam-GA. It
does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Alprazolam-
GA against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read it
again.
WHAT ALPRAZOLAM-GA IS
USED FOR
Alprazolam-GA belongs to a group
of medicines called
benzodiazepines. These medicines
are thought to work by their action
on brain chemicals.
Alprazolam-GA has sedative
effects and is used to treat:
•
anxiety. Anxiety or tension
associated with the normal
stress of everyday life usually
does not require treatment with
medicines.
•
panic attacks
Your doctor may have prescribed
Alprazolam-GA for another
purpose. ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT WHY
ALPRAZOLAM-GA HAS BEEN
PRESCRIBED FOR YOU.
In general, benzodiazepines such
as Alprazolam-GA should be taken
for short periods only (for example
2 to 4 weeks). Continuous long-
term use is not recommended
unless advised by your doctor. The
use of benzodiazepines may lead
to dependence on the medicine.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ALPRAZOLAM-GA
_ _
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE ALPRAZOLAM-GA IF
YOU HAVE HAD AN ALLERGIC REACTION
TO ALPRAZOLAM-GA OR ANY OTHER
BENZODIAZEPINES, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
IF YOU ARE NOT SURE IF YOU HAVE AN
ALLERGY TO ALPRAZOLAM-GA CHECK
WITH YOUR DOCTOR.
DO NOT TAKE ALPRAZOLAM-GA IF
YOU:
•
SUFFER

Summary of Product characteristics

Product Information - Australia
Alprazolam-GA PI v1 090508
Page 1 of 11
ALPRAZOLAM-GA
NAME OF THE MEDICINE
Alprazolam
The chemical name of alprazolam is 8-chloro-1-methyl 6-phenyl-4H-s
triazolo (4,3-alpha) (1,4)
benzodiazepine.
The chemical structure of alprazolam is shown below:
Alprazolam is a white crystalline powder, soluble in methanol or
ethanol but with no appreciable
solubility in water. It has a molecular weight of 308.76. CAS No:
28981-97-7
DESCRIPTION
Alprazolam-GA
Tablets
contain
alprazolam,
an
anti
anxiety,
benzodiazepine
derivative
chemically and pharmacologically related to other drugs of this class.
Each Alprazolam-GA 1 milligram tablet contains 1 milligram of
alprazolam. It also contains the
following inactive ingredients; cellulose - microcrystalline, lactose,
croscarmellose sodium,
magnesium stearate and indigo carmine aluminium lake.
Each Alprazolam-GA 2 milligram tablet contains 2 milligrams of
alprazolam. It also contains the
following inactive ingredients; cellulose - microcrystalline, lactose,
croscarmellose sodium and
magnesium stearate.
PHARMACOLOGY
The pharmacological properties of alprazolam in animals appear similar
to those of other
benzodiazepines, that is, it produces significant anxiolytic, muscle
relaxant, sleep promoting
and anticonvulsant effects in appropriate animal models.
The exact site and mechanism of action of benzodiazepines is unknown.
It is known that they
act within the central nervous system as selective depressants.
Clinical studies in healthy volunteers at doses of up to 4
milligrams/day and in patients with
panic disorder at doses of up to 10 milligrams/day, only produce
effects which can be
considered to be extensions of its pharmacological activity. No
clinically significant effects on
the cardiovascular or respiratory systems are apparent. Alprazolam at
doses of up to 10
milligrams/day does not clinically affect laboratory parameters or
vital signs.
Product Information - Australia
Alprazolam-GA PI v1 090508
Page 2 of 11
Sleep laboratory studies in man showed t